Valve replacement systems and methods

ABSTRACT

Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/842,206, filed Mar. 15, 2013 and claims the benefit of U.S.Application Ser. No. 61/635,741, filed Apr. 19, 2012 and U.S.Application Ser. No. 61/669,383, filed Jul. 9, 2012, the entiredisclosures of which are expressly incorporated herein.

BACKGROUND OF THE DISCLOSURE

The present disclosure relates to medical interventional systems andmethods and more particularly, to valve replacement systems and methods.The long-term clinical effect of valve regurgitation is well recognizedas a significant contributor to cardiovascular related morbidity andmortality. In particular, there are two basic classifications of mitralregurgitation (“MR”), primary and secondary. Primary MR results whenthere is either direct tissue pathology of the valve structures or thereis structural damage/alteration of one or more valve structures(leaflets, chordae). Secondary MR results from damage to the myocardiumand left ventricle resulting in left ventricular dilatation, andsecondary alteration of mitral valve geometry and functional loss ofvalve competence. Whether valvular in origin leading to a ventricularproblem or of ventricular/muscle origin leading to the valvular problem,the effect of high levels of MR is significant on cardiopulmonaryphysiology, resulting in significantly elevated left atrial pressuresand pulmonary pressures, pulmonary congestion, and volume and energyoverload effects on the myocardium. This physiology creates significantheart failure symptoms of shortness of breath and decreased physicalendurance, ultimately leading to death.

The decision to intervene on a regurgitant mitral valve relates to thelevel of mitral regurgitation, the symptoms of the patient as anindicator of progressive negative physiologic effect, and the functionalstatus of the left ventricle, specifically ejection fraction. The riskof intervention is weighed against the benefit of MR treatment.

The mitral valve is a therapeutic target of intervention/surgery earlyin the disease process of primary valvular disease because of MR'sdeleterious effects on heart/ventricular function if left untreated. Forpatients with moderate-severe or severe levels of MR combined with evena modest decrease in ejection fraction (“EF”), or the development ofsymptoms, surgical correction is indicated. In this situation, the riskof surgery in what is an otherwise healthy patient is far outweighed bythe beneficial effects of eliminating the long-term negative effects ofMR.

A more difficult question has been the patient with secondary orfunctional mitral regurgitation. In this situation, the patient haspre-existing LV dysfunction combined with heart failure symptoms, and adeveloping/worsening level of MR. The risks of intervention in thisscenario are much greater. The net benefit of surgically intervening toeliminate the MR has not been demonstrated. Symptomatic benefit has beenseen, but not a net mortality benefit. Therefore, it is usuallycontemplated or applied concomitantly when a patient is undergoingcoronary artery bypass graft CABG revascularization.

The classification of mitral regurgitation as primary or secondary is auseful to differentiate between the underlying disease processes thatled to the incompetent valve. These provide a starting point that candirect the type and timing of an intervention. However, classificationis not sufficient to fully describe the issues that direct a therapeuticapproach. Because the mitral valve is complex structurally,mechanically, and physiologically, a more detailed description andunderstanding of the abnormalities associated with mitral regurgitationis needed to direct existing therapies, as well as develop new optionsfor therapy.

Pathologic abnormality of the mitral valve tissue is a common cause ofprimary mitral regurgitation. Typical pathologies that occur includerheumatic, myxomatous, endocarditis, and Marfan's or other collagenbased tissue diseases. Calcification and leaflet thickening are alsoabnormalities associated with direct tissue level changes in the valve.These can be either part of a primary tissue based disease or resultfrom a long-standing insult to the valve, including regurgitant jettingacross the leaflets.

Congenital and acquired structural abnormalities like ruptured chordae,leaflet prolapse, fenestrations, and clefts can also be forms of primaryvalve disease leading to mitral regurgitation.

Functional MR results from myocardial damage leading to ventricularfunctional loss and geometric changes that impact the valve coaptationthrough associated annular dilatation and papillary muscle displacement.In pure functional MR, the valve structures are not pathologic nor havestructural defects, but the geometric alteration leads to a loss ofcoaptation of the mitral valve leaflets, often in the central A2/P2segment of the valve.

As with many multi-factorial clinical problems, one etiologic element(tissue pathology, structural alterations, functional/geometric changes)may lead to others resulting in a “mixed” picture. This is especiallytrue with mitral regurgitation. In the case of primary MR of eithertissue or structural origin, volume overload of the LV can createfailure and LV dilatation creating a component of functional MR if thevalve is left untreated. In the case of long standing functional MR,tissue changes can be seen such as calcification and thickening causedby the regurgitant jet and high leaflet stresses. Muscle/tissue damageto the myocardium in and around the sub-valvular apparatus can createstructural alteration such as ruptured papillary muscles/chordae andprolapse. Excessive tenting of the leaflets associated with significantfunctional MR can also stress the chords causing rupture.

The net result is that MR is a spectrum disorder with many patientshaving a mixed picture of valve abnormalities. This is an importantfactor in the decisions surrounding a mitral valve therapeutic approach,specifically repair or replacement.

The primary goal of any therapy of the mitral valve is to significantlyreduce or eliminate the regurgitation. By eliminating the regurgitation,the destructive volume overload effects on the left ventricle areattenuated. The volume overload of regurgitation relates to theexcessive kinetic energy required during isotonic contraction togenerate overall stroke volume in an attempt to maintain forward strokevolume and cardiac output. It also relates to the pressure potentialenergy dissipation of the leaking valve during the most energy-consumingportion of the cardiac cycle, isovolumic contraction. Additionally,successful MR reduction should have the effect of reducing the elevatedpressures in the left atrium and pulmonary vasculature reducingpulmonary edema (congestion) and shortness of breath symptomatology. Italso has a positive effect on the filling profile of the left ventricleand the restrictive LV physiology that can result with MR. Thesepathophysiologic issues indicate the potential benefits of MR therapy,but also indicates the complexity of the system and the need for atherapy to focus beyond the MR level or grade.

It is also desirable to prevent new deleterious physiology or functionof the valve. The procedure and system used to fix the mitral valveideally should avoid worsening other (non-MR) existing pathologicconditions or creating new pathologic conditions as a result of thetreatment of the critical factors to be managed is Stenosis/gradient.That is, if a valve system is used that does not allow for sufficient LVinflow without elevated filling pressures, then critical benefits of MRreduction are dissipated or lost. Moreover, atrial fibrillation is to beavoided as it can result if elevated pressures are not relieved by thetherapy, or are created by the system (high pressure results in atrialstress leading to dilatation ultimately leading to arrhythmias). Also,if the procedure results in damage to atrial tissue at surgery, it canresult in the negative physiologic effect of atrial fibrillation.Further, one should be aware of the possibility of increased LV WallStress (LV geometry). Due to the integral relationship of the mitralvalve with LV geometry through the papillary and chordal apparatus, LVwall stress levels can be directly affected resulting in alterations ofLV filling and contraction mechanics. Accordingly, a system that doesnot preserve or worsens the geometry of the LV can counter the benefitsof MR reduction because of the alteration of contractile physiology.

It has been generally agreed that it is preferable if the valve can berepaired. Repair of valve elements that target the regurgitant jet onlyallows for minimal alteration to the valve elements/structures that areproperly functioning allowing for the least potential for negativelyeffecting the overall physiology while achieving the primary goal.Native valve preservation can be beneficial because a well repairedvalve is considered to have a better chance of having long standingdurability versus a replacement with an artificial valve that hasdurability limits. Also, while current surgical artificial valvesattempt chord sparing procedures, the LV geometric relationship may benegatively altered if not performed or performed poorly leading to anincrease in LV wall stress due to an increase in LV diameter. Thus,while preferred and possible for technically competent surgeons, therelatively high recurrence rate of MR due to inadequate repair, theinvasiveness of the surgery especially in sick or functional MRpatients, and the complexities of a repair for many surgeons lead to ahigh percentage of mitral operations being replacement.

Conventionally, surgical repair or replacement of the mitral valve isperformed on cardiopulmonary bypass and is usually performed via an openmedian sternotomy resulting in one of the most invasive high riskcardiac surgical operations performed, especially in subpopulations suchas functional MR. Therefore, a key improvement to mitral valveoperations is to significantly lower the risk and invasiveness,specifically utilizing a percutaneous or minimally invasive technique.

While there have been attempts to replicate existing surgical repair vialess invasive surgical or percutaneous methods, given the complexity ofrepairing the valve surgically, the efforts have largely been deemedlacking in achieving adequate efficacy and have not altered the riskbenefit ratio sufficiently to warrant ongoing investment, approval, oradoption. In particular, there has been a general technology failure dueto the complexity of anatomy to percutaneously manage with an implant orimplantable procedure. The broad spectrum of mitral disease directlyinfluences outcomes with a resulting inability to match technology withpathology. There has also been observed inadequate efficacy with poorsurgical replication and safety results. It has also been recognizedthat percutaneous approaches successful to certain valve procedures,such as aortic valve replacement associated with a single pathology anda relatively circular rigid substrate, mitral valves often suffer frommultiple pathologies and a flexible or elastic annular with multiplestructures.

Accordingly, what is needed is an effective long lasting MR reductionwithout creating negative physiologic consequences to thecardio-pulmonary system (heart, lungs, peripheral vasculature) includingstenosis, LV wall stress and atrial fibrillation. It is also desirableto be able to perform the operation in a reliable, repeatable, and easyto perform procedure and to have a broadly applicable procedure for bothpatients and physicians, while employing a significantly less invasivemethod.

The present disclosure addresses these and other needs.

SUMMARY

Briefly and in general terms, the present disclosure is directed towardsvalve replacement and repair systems and methods. In one particularaspect, the present disclosure describes a percutaneous or minimallyinvasive mitral valve replacement system that eliminates MR, providesadequate physiologic inflow, and preserves and/or improves LV geometryin a reliable, repeatable, and easy to perform procedure.

In one aspect, there is provided a mitral valve replacement systemincluding an anchoring structure and an artificial valve configured totreat a native heart. In another aspect, there is provided a method ofreplacing a valve including providing anchor structure, advancing avalve delivery catheter into a heart, advancing an artificial valve outof the delivery catheter and into the heart, and positioning theartificial valve to treat a native heart.

In one approach, the mitral valve replacement system addresses a numberof basic functional requirements. One requirement is the valve functionitself, the occlusion of flow during systole, and open to flow duringdiastole. Another requirement is the seal between the artificialreplacement valve frame/structure and the tissue to prevent/minimize anyperi-valvular leaks or flow. A further requirement is the anchoring orsecurement function to hold the functioning valve in position andwithstand the substantial and variable cyclical load placed on the valveduring systolic pressurization of the valve surface. It is intended thateach of these is met in the durable, therapeutically, andphysiologically appropriate mitral valve replacement system disclosedherein.

The presently disclosed system may utilize a staged approach to thefunctional elements of the system, starting with the anchoring orsecurement functional element. Additionally, the staging can beperformed within a single procedure or in multiple, time separatedprocedures. By staging and separating functional elements, theindividual elements will be simpler in design and simpler to deploy andimplant. This staging of the anchor implantation of the presentinvention provides a stable, reliable, consistent, substrate to delivera replacement valve into the mitral position.

A mitral valve replacement system according to the present disclosureincludes an anchor element, a sealing element, and a valve element, andutilizes an anchor delivery system, and a valve delivery system. Morethan one element may be incorporated into a structure, for example, ananchor element also may comprise a sealing structure, or a valve elementmay comprise a sealing structure. In accordance with the presentteachings, the elements of the valve replacement system may be implantedin staged procedures, for example, an anchor element may be implantedduring a first procedure and a valve element may be implanted during asecond procedure. As disclosed herein, the processes, systems used forimplantation, and timing of implantation may vary. The presentdisclosure further contemplates that the anchor element (and in somecases sealing element) of the disclosed mitral valve replacement systemmay be used with existing valve technologies, as discussed furtherbelow. Similarly, delivery systems may include those disclosed herein,but the present disclosure also contemplates that existing deliverysystems may be used to deliver prior art valve structures.

Thus, in various approaches, a stable, reliable, consistent substrate iscreated by implanting an anchor structure to secure a valve withoutdisruption of native valve function until an artificial valve isoperational. Further, an anchor structure that predictably accepts anartificial valve and will seal the tissue and an implant interface isprovided as is an anchor delivery system that can accurately, simply,and reliably deliver anchor substrate structure while maintaining nativevalve function. In one particular aspect, a supra-annular ring withcommissural anchors is provided, two commissural anchors sized andshaped to correspond to valve commissures and a third anchor forplacement at a second anchor location. Anchor delivery can involveindividual, releasable control elements such that in situ access to eachanchoring location is provided in order to deploy tissue penetratingstructures for securement. Catheter/tube access is contemplated as isover-the-wire access.

It is also contemplated that current valve technologies can beleveraged. A valve to anchor interface can involve a geometricinterlock, to thereby allow the flexibility for adaptation to a broadspectrum of valve technology. In this regard, a valve to native valveinterface preserves sub-valvular structure relationships.

Moreover, the valve anchor approach can fundamentally alter thecomplexity of performing a completely percutaneous mitral replacement bycreating a reliable and consistent substrate. Thus, it is intended thatthe implant design exploit the geometry/mechanics of the commissures tocreate sufficient holding capability. Further, design and deliveryapproaches that maintain native valve function providing the ability tocompletely separate and stage the implantation of the system functionalcomponents is contemplated as are delivery methods that have potentialfor quick fluoroscopic delivery, positioning, and deployment.Consequently, there is an optimal valve performance opportunity due tomaximal design flexibility and technology leveraging, and a deliverycapability to achieve precise positioning prior to valve deployment. Thesame creates desired tissue/implant sealing and maintains sub-valvularstructural relationships.

Accordingly, employing the present system and method facilitateseffective long lasting MR reduction without creating negativephysiologic consequences to the cardio-pulmonary system (heart, lungs,peripheral vasculature) including stenosis, LV wall stress, and atrialfibrillation. The method can involve performance of the operation in areliable, repeatable, and easy to perform procedure and is a broadlyapplicable procedure for both patients and physicians. A significantlyless invasive method results, one which can be fully percutaneous fromthe start.

Other features and advantages of the present disclosure will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are graphical representations, depicting characteristicsof potential patient populations;

FIG. 2A is a schematic drawing of the mitral valve anatomy at the levelof the mitral annulus;

FIG. 2B is a side view, depicting a portion of the schematic from FIG.2A;

FIG. 2C is a schematic section view of the mitral commissural area,showing the region of possible anchor and/or anchor projection tissueengagement;

FIG. 2D is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting possible locations for attachmentof the anchor to the valve tissue or anatomy;

FIG. 2E is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the commissural and posteriorleaflet cleft locations as possible attachment locations for the anchor;

FIG. 3 is a vertical cross-section of the heart, depicting the posteriorwall of LV with an exemplary anchor embodiment;

FIG. 4 is a transverse (short axis) cross section of the heart,depicting the mitral valve annular level of the exemplary embodiment ofFIG. 3, showing the circular anchor structure;

FIG. 5 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting the anchor of FIG. 3;

FIG. 6 is a vertical cross-section of the heart looking at the posteriorwall of LV, depicting another anchor structure;

FIG. 7 is a cross section view of the anchor structure of FIG. 6 takenat the natural cleft, depicting capture of the anterior and posteriorleaflet;

FIG. 8 is a cross section view of an anchor, depicting the P2 segment ofthe posterior leaflet;

FIG. 9 is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the anchor structure of FIGS. 6and 7.

FIG. 10 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting the anchor of FIGS. 6 and 7.

FIG. 11 is sectional view of an anchor structure and the heart at thecommissural location;

FIG. 12 is a sectional view to FIG. 11, with penetrating projections anda flattened structure at tip to create a mechanical hold;

FIG. 13 is cross section of an anchor structure and the heart at thecommissural location, showing the anchor structure that has geometricinterference to the wall beneath the leaflet;

FIG. 14 is a transverse (short axis) sectional view at the mitral valveannular level, showing the anchor of FIG. 13 at the anterior commissurallocations;

FIG. 15 is a transverse (short axis) sectional view, depicting anotherembodiment of an anchor;

FIG. 16 shows a top view of an embodiment of an anchor structure in thenondeployed or delivered state prior;

FIG. 17 is an magnified partial view, depicting a penetrating structureof FIG. 16 taken from between points A and B in FIG. 16;

FIG. 18 is a top view of the structure of FIG. 16, depicting a deployedconfiguration;

FIG. 19 is a magnified partial top view, depicting an alternativepenetrating structure;

FIG. 20 is a front view, depicting an alternative approach to apenetrating structure;

FIG. 21 is a side view, depicting structure of FIG. 20;

FIG. 22 is a transverse view, depicting another anchor wire framestructure;

FIG. 23 is a transverse view, depicting a wire frame anchoring structure

FIG. 24 is a transverse view, depicting another anchor wire frame;

FIG. 25 is a transverse view, depicting yet another anchor structure;

FIG. 26 is a cross-sectional view, depicting still yet another anchorwire frame;

FIG. 27 is a transverse view, depicting the anchor wire frame of FIG. 26

FIG. 28 is a transverse view at the level of the mitral annulus,depicting an anchor structure that has a interconnecting cross member;

FIG. 29 is a transverse view, depicting the anchor of FIG. 28;

FIG. 30 is a vertical cross-section of the heart looking at theposterior wall of LV, depicting an exemplary anchor wire frame;

FIG. 31 is a view from above the annulus, depicting the anchor frame ofFIG. 30.

FIG. 32 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, showing the anchor frame of FIGS. 30 and31.

FIG. 33 is a vertical cross-section of the heart looking at theposterior wall of LV, depicting an anchor wire that includes a crossmember;

FIG. 34 is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the anchor frame of FIG. 33;

FIG. 35 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, showing a view of the anchor frame of FIGS.33 and 34;

FIG. 36 is a vertical cross-section of the heart looking at theposterior wall of LV, depicting another anchor wire frame;

FIG. 37 is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the anchor frame of FIG. 36;

FIG. 38 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, showing a view of the anchor frame of FIGS.36 and 37;

FIG. 39 is a side view, depicting an anchor structure with a saddleshape;

FIG. 40 is a view of an anchor structure that has an arc section;

FIG. 41 is a side view, depicting an exemplary anchor structure that hasa serpentine wire frame;

FIG. 42 is a top view, depicting an anchor structure that has aserpentine wire frame;

FIG. 43 is a cross-sectional view, depicting an adjustable anchor wireframe;

FIG. 44 is a section view of the commissural region, depicting structurefor direct mechanical load support of the anchor;

FIG. 45A depicts a section view at the region of the fibrous trigonestructure to provide direct mechanical load support to an anchor;

FIG. 45B depicts an anchor structure to create a dimensionalinterference;

FIG. 45C depicts the anchor structure and illustrates shear loading ofthe anchor/tissue interface;

FIGS. 45D-45F depict various anchor configurations that abut the LVwall;

FIG. 46 is a partial section view, depicting the deployed configurationof an anchor;

FIG. 47 is a side view, depicting the anchor of FIG. 46;

FIG. 48 is a section view, depicting the anchor of FIGS. 46 and 47;

FIG. 49 is a cross-sectional view, depicting the anchor of FIGS. 46-48in a predeployed state;

FIG. 50 depicts a deployed leaflet clip;

FIG. 51 is a section view, depicting the deployed leaflet clip of FIG.50;

FIG. 52 is a top view, depicting an anchor structure for attachment tothe fibrous region of the trigone;

FIG. 53 is a side view of the mitral annulus, depicting a portion of theanchor structure of FIG. 52;

FIG. 54 shows a penetrating anchor securement element that utilizes ahelical screw;

FIG. 55 shows a penetrating anchor securement element that utilizes awire brush;

FIG. 56 shows the securement element of FIG. 55 in position in a sectionview of the mitral annulus;

FIG. 57 shows a penetrating anchor securement element that utilizes ahelical screw;

FIG. 58 shows an exemplary penetrating anchor securement element;

FIG. 59 shows another penetrating anchor securement element;

FIG. 60 shows yet another penetrating anchor securement element;

FIG. 61 shows a generic penetrating securement element that is placed ina position further down into the LV;

FIG. 62 is a transverse (short axis) cross section view of the heart atthe mitral valve annular level, depicting an embodiment of a circularanchor structure;

FIG. 63 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting the structure of FIG. 62;

FIG. 64 is a vertical cross section of the heart looking at theposterior wall of LV and the mitral valve, depicting an embodiment of asealing skirt structure;

FIG. 65 is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the sealing skirt of FIG. 64;

FIG. 66 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting the sealing skirt of FIGS. 64 and65;

FIG. 67 is a collapsed view of the valve and sealing skirt of FIGS. 64and 65;

FIG. 68 is a side view, depicting an embodiment of a sealing structure;

FIG. 69 is a side view of a sealing structure of FIG. 68;

FIG. 70 is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the sealing structure of FIG. 69;

FIG. 71 is a vertical cross section looking at the posterior wall of LVand the mitral valve, depicting the sealing structure of FIGS. 69 and70;

FIG. 72 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting the sealing structure of FIGS. 69and 70;

FIG. 73 is a vertical cross section looking at the posterior wall of LVand the mitral valve, depicting an embodiment of a sealing structurethat has a frame;

FIG. 74 is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the sealing structure of FIG. 73;

FIG. 75 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting the sealing structure of FIGS. 73and 74;

FIG. 76 is a vertical cross section looking at the posterior wall of LVand the mitral valve, depicting another embodiment of a sealingstructure;

FIG. 77 is a transverse (short axis) cross section of the heart at themitral valve annular level, depicting the sealing structure of FIG. 76;

FIG. 78 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting the sealing structure of FIGS. 76and 77;

FIG. 79 is a cross-sectional view, depicting the sealing structure ofFIG. 76;

FIG. 80 is a top view of the exemplary assembly of FIG. 79 showing thebi-leaflet valve;

FIG. 81 is a top view, depicting the assembly of FIG. 80;

FIG. 82 is a cross section, depicting the structure of FIG. 81;

FIG. 83 is a top view, depicting a sealing structure frame with fabriccovered wire mesh;

FIG. 84 is a top view, depicting an expandable metal mesh sealingstructure;

FIG. 85 is a vertical cross section looking at the posterior wall of LVand the mitral valve, depicting a sealing structure that has a flexiblesealing skirt;

FIG. 86 is a transverse view at the mitral level, depicting the sealingstructure of FIG. 85;

FIG. 87 is a section view of the sealing structure of FIG. 85 in avertical cross section through the aorta and the A2/P2 segment of themitral valve;

FIG. 88 is a vertical cross section through the aorta and the A2/P2segment of the mitral valve, depicting yet another embodiment of asealing structure;

FIG. 89 is a vertical section view of the structure of FIG. 88;

FIG. 90 is a top view of the structure of FIGS. 87 and 88;

FIG. 91 is a side view, depicting an anchor/valve interface structure;

FIG. 92 is a cross section of the structure in FIG. 91;

FIG. 93 is an alternative profile to the cross section of FIG. 92;

FIG. 94 is a side view, depicting sealing structure in the form of afolded and balloon expanded metal frame;

FIG. 95 is a cross-sectional view, depicting the device of FIG. 93;

FIG. 96 is a side view, depicting an embodiment of an anchor/valveengagement structure comprising a slotted tubular metal frame;

FIG. 97 is a side view, depicting the frame of FIG. 96;

FIG. 98 is a side view, depicting a slotted tubular metal frame;

FIG. 99 is a side view, depicting the anchor engagement structure ofFIG. 98;

FIG. 100 is a sectional view of the heart, depicting showing anembodiment of a mitral valve replacement system;

FIG. 101 is a top view, depicting the system of FIG. 100;

FIG. 102 is a section view with the heart in a cross section along theaorta and A2/P2 section of the mitral valve, depicting the structure ofFIGS. 100 and 101;

FIG. 103 is a cross-section view, depicting a structural relationship ofan expanded valve and an anchor;

FIG. 104 is a side view, depicting a valve replacement system includinga valve;

FIG. 105 is the view of the posterior wall of the valve, depicting thesystem of FIG. 104;

FIG. 106 is a top view, depicting the exemplary system of FIGS. 104 and105;

FIG. 107 shows a cross-sectional view, depicting an alternativeembodiment for anchoring the system of FIG. 104;

FIG. 108 is a top view, depicting the valve and hook structure of FIG.107;

FIG. 109 is a cross sectional view, depicting a sealing mechanismcomprising a membrane perimeter;

FIG. 110 is a side view, depicting the sealing structure of FIG. 109;

FIG. 111 is a top view, depicting the structure of FIGS. 109 and 110;

FIG. 112 is a side view, depicting a wire frame structure attached tothe artificial valve;

FIG. 113 is a sectional view, depicting sealing structure for theartificial valve frame to native leaflets;

FIG. 114 is a sectional view, depicting wire structure that can be usedto secure the leaflets;

FIG. 115 is a sectional view, depicting the structure of 114;

FIG. 116 is side view, depicting a guidewire placed in the LV;

FIG. 117 shows the placement an intraventricular guide catheter used forthe anchor delivery and orientation of the tip toward the mitralorifice;

FIGS. 118 and 119 show the placement of a guidewire across the mitralorifice in a long axis and short axis heart views, respectively;

FIG. 120 shows the retraction of an expanded wire cage structure backthrough the mitral orifice;

FIG. 121 shows a transverse cross section, depicting the cage;

FIGS. 122 and 123 show long axis and short axis views, depicting theadvancement of an anchor delivery catheter over the previously trackedwire;

FIG. 124 shows the advancement and unfolding of an anchor in the leftatria;

FIG. 125 is a transverse short axis view, depicting the unfolded anchor,delivery wires and connections to frame, and the delivery catheter ofFIG. 124;

FIG. 126 is a vertical long axis view, depicting the anchor in positionafter the delivery catheter has been pulled beneath the valve;

FIG. 127 is a transverse section view, depicting the anchor of FIG. 126;

FIG. 128 is a transverse cross section depicting a shaft separator;

FIG. 129 is a transverse cross section, depicting a shaft separator;

FIG. 130 is a vertical long axis, depicting the shaft separator of FIG.128;

FIG. 131 is a transverse cross section at the mitral leaflet level,depicting the shaft separator of FIGS. 128 and 129;

FIG. 132 is a perspective view, depicting the shaft separator of FIG.128;

FIGS. 133 and 134 are cross-sectional views, depicting the deliverycatheter arrangement for securement elements;

FIG. 135 is a perspective view, depicting an alternative structure forreleasing the anchor structure;

FIG. 136 depicts the first stage of an exemplary procedure forpercutaneous delivery of the artificial mitral valve;

FIG. 137 depicts the transvenous, trans-septal access catheter inposition that is used to deliver the valve into the anchor structure;

FIG. 138 depicts the next stage in the deployment of a percutaneouslydelivered, generalized artificial mitral valve of the present disclosureinto the anchor structure previously positioned;

FIG. 139 shows radiopaque markers on both the anchor structure(rectangles) and the artificial valve (circles);

FIG. 140 depicts the structures of FIG. 138 with the valve having beenadvanced into proper axial location;

FIG. 141 depicts markers used to facilitate rotational alignment of thevalve;

FIG. 142 depicts the structures of FIG. 141 with the valve deployed;

FIG. 143 is a side view, depicting a less invasive delivery of amechanical valve into the mitral position via a trans-atrial approach;

FIG. 144 is a side view, depicting the system of FIG. 143 showing themechanical valve rotated inside the left atrium;

FIG. 145 is a side view, depicting the system of FIGS. 143 and 144;

FIG. 146 is a side view, depicting the mechanical valve deployed inposition;

FIG. 147 is a side view, depicting a less invasive delivery of amechanical valve;

FIG. 148 is a side view, depicting the system of FIG. 147;

FIG. 149 is a side view, depicting the system of FIGS. 147 and 148; and

FIG. 150 is a side view, depicting the mechanical valve deployed inposition.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, which are provided by way of backgroundand example, and not limitation, the present disclosure relates tomedical interventional procedures and devices. In various aspects, heartvalve repair is addressed and in particular, mitral valve replacementapproaches are presented.

With reference to FIGS. 1A-B, there is shown a graphical representationof a potential patient population suffering from MR. Patients areclassified by valve abnormality versus the severity of symptoms (i.e.ejection fraction). A decision to be made involves whether to replace orrepair the subject valve. However, it has been found that a majority ofpatients with MR are left untreated. This is especially true withfunctional MR. It has been determined that such patients can be treatedusing a percutaneous mitral valve replacement approach.

In open surgical valve replacement, the valve is implanted in itsfunctional configuration and size. Additionally, conventional artificialsurgical valves have a sewing ring around their perimeter that isdirectly attached to the valve annulus tissue with multiple sutures toprovide both the securement and sealing functions. The surgical approachrequires sternotomy, the heart to be stopped (cardiopulmonary bypass)and the atrium to be opened.

For less invasive, beating heart approaches to valve replacement, (suchas is performed in the aortic valve) whether trans-apical access orendovascular access (venous/antegrade, arterial/retrograde), the valveis not in a functional configuration and is in a compressed state to aiddeployment. This requires the valve to be deployed by some means toachieve its functional configuration and size. These proceduraloperations of deploying a functional valve, a tissue sealing structure,and a load bearing anchor structure that is solidly secured and sealedto the native anatomic location must be performed quickly and remotelyto accommodate the desired less invasive and beating heart implantation.This combination of multiple deployable elements with multiplefunctional requirements of the composite system dramatically increasesthe complexity of the system and procedure.

In general, the most difficult of the three functions to reliablyachieve can be the anchoring function due to the variable and cyclicalload requirements and the complexity of the anatomic structures of thenative mitral valve. The sealing function of the system is similarlydifficult because of the pressure requirements and again, the complexityof the anatomic structures of the native mitral valve. The simplest isthe deployable valve functional element, as the TAVI experience providesa basis for the starting point design structures and mechanisms.

It is desirable to have a simple and repeatable procedure to deliver ahighly functional and long lasting valve system requires a differentapproach than currently being pursued by others in the field.

In particular, a mitral valve replacement system according to thepresent disclosure includes an anchor element, a sealing element, and avalve element, and utilizes an anchor delivery system, and a valvedelivery system. More than one element may be incorporated into astructure, for example, an anchor element also may comprise a sealingstructure, or a valve element may comprise a sealing structure. Inaccordance with the present teachings, the elements of the valvereplacement system may be implanted in staged procedures, for example,an anchor element may be implanted during a first procedure and a valveelement may be implanted during a second procedure. As disclosed herein,the processes, systems used for implantation, and timing of implantationmay vary. The present disclosure further contemplates that the anchorelement (and in some cases sealing element) of the disclosed mitralvalve replacement system may be used with existing valve structures, asdiscussed further below. Similarly, delivery systems may include thosedisclosed herein, but the present disclosure also contemplates thatexisting delivery systems may be used to deliver prior art valvestructures.

It should be noted that in planned percutaneous structural heartinterventions (TAVI, mitral repair, mitral replacement) (i.e.percutaneous), there are at least two procedures performed for eachindividual patient. The first procedure includes a diagnostic assessmentand possible PCI/stenting of the patient's coronary arteries and oftenincludes a right heart cath for cardiac physiology assessment. Valveimplantation and or repair is not performed prior to knowing the patienthas been previously completely revascularized if necessary.

As mentioned, generally the most difficult and most significantrequirement for a less invasive valve system is the anchoring attachmentof the system. The presently disclosed mitral valve replacement systemstaging of the anchor implantation allows exploitation of variousanatomic valve and ventricular structures to achieve the requiredholding force of the anchor system. When performed in two time separatedprocedures, staging the implantation of the anchor separately from othersystem elements provides time for tissue ingrowth into the anchorstructure and resultant strengthening of the overall holding force ofthe anchor structure in the anatomy.

Staging of anchor implantation allows for maintaining native valvefunction until artificial valve element(s) are in place.

Anchor element embodiments disclosed herein may utilize and exploitanatomic structures and geometry to attain the required mechanicalholding forces whether engaged acutely or chronically with the additionof tissue ingrowth of the anchor.

As noted above, the sealing element (non-valvular) can either be astructure distinct from the primary tissue anchor or valve elements, incombination with the anchor, or in combination with the valve. Whenprovided in combination with the anchor structure, a possibility is thatthe sealing and anchoring functions can both benefit from tissueingrowth and incorporation of the anchor implant structure. This wouldallow for a sealed tissue/anchor implant interface that could be engagedby the valve structure element without the need for additionalstructures/elements to seal between the valve and tissue.

This situation provides the stable, predictable substrate to receive anddeploy an artificial valve into the mitral position. The predictablesubstrate significantly alters and reduces the requirements placed onthe valve for both delivery and deployment, making it more analogous tothe aortic percutaneous valves that utilize the generally circular,tubular and solid (calcified) aortic root to attach and seal. It mayeven provide the benefit of having a more reliable substrate due to thelack of calcified deposits that affect valve shape and function in thecurrent TAVI valves that can lead to peri-valvular leaks.

Yet another aspect of staging is the ability to stage the actualvalve/occluder function. In this approach, a non-functional valvestructure could be deployed in the same procedure as that of theimplantation of anchor and sealing structures, but since the valve isnon-functional, the loads encountered by the system would besignificantly less than those encountered by a fully functional valve,reducing the load placed on the anchor element. As the anchor andsealing structures grow into and are incorporated in the tissue/existinganatomy, the holding capability of these structures increases until suchtime as the valve/occluder function is deployed, either automatically(e.g., suture dissolving over time) or by some trigger mechanism oractuation during a second procedure. This actuation could be achievedremotely without invading the body (e.g., RF or ultrasound-likeactuation).

The valve replacement system according to the present disclosure allowsfor valve delivery flexibility without, or only minor non-critical,alteration of the final implant. Specifically, tissue valves can bedelivered either via a fully percutaneous procedure or a minimallyinvasive surgical delivery of the valve without modification to thevalve implant to accommodate the alternative route.

Another aspect of staged implantation of anchor and valve structures isthat previously developed technology for deployable valves in the aorticposition may be able to be extensively leveraged for use in the mitralposition, i.e., minimal modification of existing valve structures maypermit their use in the mitral space.

Yet another aspect of having a stable consistent anchor platform forreceiving a valve structure is that it allows for valve sizing that isappropriate for the patient population (FMR, structural, mixed) and evenspecific to the patient being treated. In other words, it allows for thelargest valve possible in every patient rather than compromising size(smaller than physiologically desired) to accommodate technologylimitations in systems that must combine multiple (increase complexity)valve, attachment, sealing and delivery structures.

The system according to the present teachings also allows fortherapeutic flexibility of the artificial valve. The presently disclosedsystem allows for beating heart implantation of both tissue andmechanical valves. As disclosed herein, delivery systems are providedthat allow implantation of mechanical valves via either a trans-apicalor trans-atrial thorascopic route.

Overall, the present disclosure describes a system including a platformanchor, valve, and delivery technology that allows therapeuticflexibility (mitral replacement with either tissue or mechanicalvalves), implantation flexibility via either fully percutaneous orminimally invasive (trans-apical, trans-atrial) procedures, minimizeddelivery complexity to allow a simple to perform procedure, and apatient population that is not restricted by the underlying pathology.

It is contemplated that the structural substrate of the mitral annularbe managed. Also, the mitral annulus is typically nonplanar,non-circular in shape, flexible and distensible. These all contribute toa complex substrate to effectively attach an artificial valve, andspecifically the anchor structure. Complex valve/ventricle structuralrelationships should be managed. The apparatus of the mitral valveincludes multiple leaflets with multiple lines of coaptation allconnected via chordae tendinae at the leaflet tips to the LV wall orpapillary muscles. This creates possible of entanglement of systemelements during implantation and if the subvalvular apparatus is notmaintained or is damaged, the LV geometry may be negatively alteredincreasing LV wall stress and reducing overall cardiac function in spiteof the artificial valve eliminating MR. Moreover, the load requirementare contemplated to be managed. The static functional load on theimplanted artificial valve may be calculated by Valvearea×Trans-valvular (LV pressure—left atrium pressure) pressure. This isgenerally approximately 3 pounds with a range of 1-4 pounds. Because themitral valve is in a cyclical flowing system, the requirements ofhandling the pressure load is accentuated by a closure or impact loadcreated by stopping the momentum effect of the LV pressurized blood. Theblood that starts to flow back towards the atrium during systole must bedecelerated. And diverted to the aortic outflow.

Another aspect is consideration of the anchor implant is the loaddistribution or force per unit of area of anchor attachment. This can beat a level that does not allow the anchor structure(s) to pull out ofthe tissue once attached. One mechanism to minimize is to have arelatively rigid anchor frame such to help distribute the valve loadacross the entire anchor surface in contact or attached with the tissue.Another mechanism is to have multiple points of attachment along theanchor. The tissue anchor geometry is another structural designconsideration in order to prevent tissue migration or pull through dueto excessive local forces or tissue necrosis that can be encounteredwhen the tissue is overcompressed. To maximize acute mechanical hold inthe tissue, the profile geometry of the anchor tissue element can bedesigned to maximize the breadth and depth of tissue engagement as wellas the surface width and geometry of the penetrating element. The tissueused to provide the holding force for the anchor can be exploited suchthat certain regions of the mitral valve have greater intrinsic tensilestrength (e.g. trigone region) or utilize tissue that has a responsethat enhances the extent (thickness, area) of ingrowth (LV muscle wall).The tissue collagen orientation in certain regions needs to be accountedfor if it is small chain, non-oriented fibers or can be used to maximizehold if it is larger chain and oriented collagen.

Due to the continuous and cyclical loads and motion of the system,anchor device biostability can be required, specifically fatigueresistance, corrosion resistance and overall mechanical durability. Oneof the system elements is intended to interface with tissue to form aseal. This can be the anchor forming the seal and the valve seals to theanchor, or the anchor holds valve and a valve element seals to thetissue. The implanted valve interface to anchor can provide sufficientand stable holding capability with a transfer of the valve loadeffectively onto the anchor. This may be accomplished by a frictionalfit via expansion (balloon, self) of the valve into the anchor and/ortissue or a mechanical interlock mechanism between the anchor and valve.Further, the anchor implant structure can be a biocompatible device,including specific biocompatibility for blood contact and tissuecontact.

The specific anatomic locations that may provide mechanical andstructural attachment of the anchor is another area of consideration.The anchor may be designed to incorporate one or more of a commissurallocation such as the anterior trigone region or the posterior leafletcleft. An attachment location could also be the anterior portion of anatrial wall, or at an annular region/surface (posterior or anterior).Leaflet capture is also contemplated such as at the sub-posteriorleaflet or the sub commissural leaflet. Attachment can also be at orwithin the left ventricle (endocardial) such as to the posterior wall(including posterior leaflet capture or a papillary space wedge), theapical/sub-papillary, the anterior/posterior wall bridge, ortransmurally (septal, free wall, apex).

The anchor itself can include various approaches to support the skeletalstructure. In one approach, the structure can be a supra-valvularstructure with commissural feet. The commissural feet/projections can bestructures which are multi-functional elements that can providemechanical/geometric anchoring, penetration (needle/barb like)securement, and tissue based incorporation (in-growth) includingsubvalvular/sub-leaflet structures that extend into the LV wall, all ofwhich do not interrupt leaflet, chordae or native valve function. Also,they can provide a positioning basis for the entire anchor because oftheir engagement with the commissural clefts in the anterior andposterior leaflets while still avoiding interaction or disruption of thechordae or native leaflets. More detail on specific methods of theanchor/tissue interface are described below.

The ring or top structure can be designed to provide a relativelycircular, non-distensible, non-elongating homogeneous frame substratethat the artificial valve can engage and attach to during itsdeployment. This can be adapted to function much like the calcifiedaortic root for TAVI without the in-homogeneity or need forpre-dilatation. This structure may be continuous or interrupted, andcompletely around annulus or only partially around annularcircumference. In particular, it can be sinusoidal in plane of valveleaflets trying to create continuous attachment around entirecircumference (each sinusoid comes in and out of plane) or sinusoidalperpendicular to valve bridging from point to point creating, multipleattachment points, thereby allowing for tissue ingrowth betweensinusoidal points of native leaflet or annulus tissuecontact/engagement. The anchor can be malleable with points ofattachment between commissures, a single wire or multiple connected wirecomponents, or be formed into a saddle configuration to approximatenatural saddle geometry of valve (may be based off of 3d echo or CT todetermine geometry).

There may further be a covering of the skeletal frame. The covering ofthe anchor skeleton can provide opportunity for facilitating collagentissue ingrowth into or onto the implant structure and/or covering inlocations such as on top (atrial side) of leaflet or annulus, at side ofleaflets or annulus, at a ventricular wall at sub-valvular level, orunderneath (ventricular side) of the leaflet or commissures.

A superstructure above the valve annulus may provide options for valveattachment to the anchor or even an alternative therapy such as mitralrepair via a septal lateral cinch. Various superstructures above theannulus can include A2 P2 points of attachment, two circles to allow fordouble aortic valves, or use of the atrial wall behind A2 or P2.

Materials for components used in multiple combinations andconfigurations, may include metals, especially for the anchor skeletonor frame structures such as Nitinol because of its superelasticity andability to be compressed into a deliverable shape/state and thendeployed into a functional state, titanium due to its strength andbiocompatibility, SST: hardened for its strength or malleable to aid inconforming to shape, cobalt/chromium alloy for strength and known valvecomponent implant history; or composites to provide multiple propertiesbased on anatomic location. Tissue elements also may be incorporated onthe anchor implant to aid overall function of holding or tissueengagement and sealing including pericardial (bovine, ovine, porcine)tissue or valve tissue (bovine, ovine, porcine). Further syntheticpolymers can be used as biocompatible elements in implants and on theanchor due to their know tissue and blood compatibility properties.These can include Elast-Eon (a silicone and urethane copolymer), ePTFE,urethane, silicone, PEEK, polyester (PET), or UHMWP.

The anchor implant can use one or more mechanisms to achieve the stable,reliable, and consistent holding forces necessary for the overallsystem. The anterior commissural/trigoneal region has been found to be aconsistent and predictable anatomic feature across multiple patientpopulations. The projections or feet placed in this area will haveminimal or no impact on native leaflet and valve functions. It is alsoan area that accommodates the anchor structure to have contact with thesupra, intra, and sub valvular structures including the LV wall beneathand behind the commissural leaflet. The tissue substrate of this area isalso very advantageous as the trigone/annulus consists of highlyorganized and strong collagen and the well perfused muscle tissueprovides a good ingrowth substrate for added chronic stability.

Geometric/mechanical holding force for anchor that exploits thegeometry/configuration of anatomic structures (relative to force vector)to achieve the necessary holding force required by a deployed artificialvalve or other therapeutic element is further contemplated. The forcevector encountered by the anchor structure's commissural projections aresubstantially under shear loading verses a perpendicular load relativeto the tissue. Commissural projections or foot elements that are able todeploy behind the anterior and posterior leaflets in the cul de sacwhere the leaflet meets the annulus provides for direct mechanicalholding capability. The commissural projections of the anchor structureconnected and bridged to each other provide an ability to create amechanical wedge structure to resist the force and hold the valve inposition. LV wall projections of the commissural feet can provide forthe ability to develop deep tissue penetration elements into the muscle,wider elements to increase surface area of contact/attachment, andlonger projections to increase capability. Moreover, because theprojections can be placed such that they are Supra annular andSub-annular, a C like structure in cross section can be utilized that iseither connected or clamped. With regard to tissue penetration basedsecurement, direct mechanical holding force is contemplated for ananchor that utilizes the natural strength of the LV and leaflet tissuesto hold onto anchor structure. These elements can be configured toeither be inserted into the tissue and resist pull out (barb like), orthey may go into and out of tissue to provide a tissue “bite” like astitch, or both elements can be employed. The structure can be locatedposterior annulus or entire annular perimeter, or adjacent leaflettissue, the trigone/anterior annulus, an endocardial LV surface or LVMuscle tissue. Further, the tissue penetration securement elements canbe linear (staple or nail like), helical (rotation axis is perpendicularto tissue interface or rotation axis is parallel to tissue interface(in/out/in/out)), curved and or curled, or bent (L shaped or S shaped).

It is also contemplated to use chronic ingrowth to provide long termstable implantation of the artificial valve and proper sealing function.In addition, chronic ingrowth of implant structural elements can serveas a fundamental mechanism to achieve the necessary holding force of theanchor functional element of the system. It exploits the natural healingresponse to foreign bodies placed into tissue and the blood stream todevelop a strong collagen based tissue connection between the implantsurface structures and the native valve tissue with a possibleendothelial surface. This can be achieved while still managing theresponse to prevent unwanted damage to anatomic structures, damage toblood elements, or creation of thromboemboli.

More areas of consideration are the surface composition elements,specifically the material choice and texture to promote tissue reactionand device incorporation with maximal force holding capability. Theseelements can also be incorporated onto the tissue penetration elementsto further increase the holding force by incorporation deep into tissuerather than just at the surface. The anchor can have a gross surfacemodification (barbs, slits), a surface texture/pores to promote ingrowthand mechanical hold, a fabric material covering (Dacron velour, doublevelour, ePTFE), a wire brush (multiple short wire elements) or anadhesive. There can further be a single or multiple points ofattachment, planar attachment or by way of a confluent surface.Moreover, the tissue/anchor interface can be rigid or flexible and caninclude a wire frame structure that puts a compressive force ontosurface contact interface to promote increased response. Also, tissuesurface modification can include an abrasive, a chemical irritant topromote inflammatory response or application of heat.

In current conventional approaches to valvular intervention, adiagnostic echocardiograph is initially performed to assess valvefunction followed by two percutaneous procedures. First, a diagnosticangiography is performed with or without a right heart catheterizationto assess, for example, whether they might also requirerevascularization first, prior to valve intervention. Here, patients donot receive valve therapy without the patient being fullyrevascularized. Thereafter, at a different time and place, valvereplacement therapy is performed involving fixation/attachment,accomplishing a tissue sealing interface, and valve deployment and thenrelease. In contrast, the presently described approach, however, caninclude an assessment involving a diagnostic echocardiography followedby a unique percutaneous valve procedure sequencing. First, a diagnosticangiography (+/− right heart cath) can be performed along with anchorfixation/attachment and anchor/tissue sealing. Subsequently, eitherlater or during the same interventional procedure, valve replacementtherapy can occur involving valve deployment and release. Thus, sincethe anchor implant allows the native valve to remain functional, theanchor implantation procedure could be added to the end of the angio(+/− PCI), and not require a separate interventional procedure. A quick,simple, and reliable anchor deployment could permit a fully ingrownstructure that significantly enhances the holding force of asubsequently implanted replacement valve. Tissue ingrowth of the entireanchor perimeter, or at key positions thereon, can in fact provide thenecessary tissue seal in advance of valve deployment. Moreover, theanchor design could be simplified due to less required acute holdingforce. Therefore, a tissue incorporated and healed anchor provides astructure to perform several methods of annular adjustment, includingplication, reduction annuloplasty, and septal-lateral cinching.

There are certain desirable anchoring locations for an anchor implant.Direct attachment to tissue is contemplated at locations adjacent themitral valve, as are locations for placement of anchor projections atleaflet cleft locations. Again, it is intended that there be low or noimpact to native leaflet function as a result of the implantation of ananchor implant, so as to maintain the pre-existing native valve functionuntil a replacement valve is implanted. At the mitral valve 50 (SeeFIGS. 2A-2E), there is of course the mitral annulus 52 definingstructure from which the anterior leaflet 54 and posterior positionleaflet 56 extend and articulate. Between the anterior and posteriorleaflets 54, 56 are commissural leaflets 58. The trigones 60 arepositioned at a perimeter of the anterior leaflet 54 and adjacent thecommissural leaflet 58. Commissures 62 are the openings or slitsdividing the anterior leaflet 54 form the commissural leaflets, andpositioned near the trigones 60. Such structure defines consistent andpredictable anatomical features across patients. Notably, the highcollagen annular trigone 60 generally can be relied upon to present astrong anchoring location. The muscle tissue in this area also providesa good ingrowth substrate for added stability. There is also a potentialfor sub-leaflet attachment for more stability (See FIG. 2C).Accordingly, primary anchoring locations 62, 64 for an anchor implantare included in FIGS. 2D and 2E.

Turning now to FIGS. 3-5, there is shown one embodiment of an anchorimplant 100 configured for atrial anchoring and implantation within theheart 102 at the mitral valve annulus 104. The anchor implant defines asupra-annular ring sized and shaped to be placed at the annulus, andincludes commissural projections 106. As shown in FIG. 3, theprojections 106 can be placed at an anterior commissural trigone 108. Asdescribed above, the commissural projections 106 are configured toextend between leaflets 109 without interfering with their functions(See FIG. 4). Moreover, as shown, the implant 100 includes a generallycircular body 110 which can be formed from a wire or other structure,and the projections 106 are loops extending away from a plane defined bythe circular body 110. It is to be further recognized that the body 110includes a pair of bends 112 configured on opposite sides of theprojections 106 to thereby provide necessary stress relief and clearancefor the placement of the projections between leaflets 109. Furthermoreas noted previously, the anchor 100 can be covered with variousmaterials, such as PET and ePTFE, so as to present a desiredbiocompatible surface to body tissue.

As shown in FIGS. 6-10, various other approaches to the anchor implantare contemplated. As before, the anchor 120 can be placed at the mitralvalve annulus 104 with projections extending beyond and between theleaflets 109. The projections 125 can be one or more of an expandingstructure deployed through the coaptation line and below the leaflet 109thereby capturing the anterior and posterior leaflet adjacent thecommissures (See FIG. 7) or can define a piercing anchor 126 (See FIG.8). In a further aspect, the piercing anchor 126 can be deployed in theP2 segment 128 of the posterior mitral valve leaflet, for example (SeeFIG. 9), so that the leaflet is punctured and captured by the anchor120. Thus, a further secure attachment in anatomy can be achieved by wayof expanding anchor or piercing anchor structure.

Two additional approaches to penetrating projections for use inconnection with an anchor implant are shown in FIGS. 11 and 12. In oneapproach (FIG. 11), a projection 130 can form a hook-like member with abarb 132 at its terminal end. Such structure defines a geometricinterference with wall anatomy below a leaflet and the barbed end 132penetrates the tissue of the LV to provide a secure attachment.Alternatively, a projection 134 can be configured to penetratecommissural anatomy and terminate with a T-bar 136 which engages anexternal wall of the LV to thereby provide a secure attachment.

Non-penetration or non-piercing projections are also contemplated. Asshown in FIG. 13, a projection 140 can be contoured to match a profileof the wall beneath a leaflet, and further include a foot pad 142 forengaging tissue. As shown in FIGS. 14 and 15, the anchor implant caninclude a plurality of projections 144 having a looped shape andincluding webbing 146 for tissue ingrowth. Here, the looped structure ofthe projections 144 include a neck sized to fit between commissuralslits and about commissural leaflets, the loop structures residing belowthe leaflet and against the LV wall to provide a secure engagement.

In another approach (See FIGS. 16-19), the anchor implant 150 can definean expandable body. In a compressed or contracted state (FIG. 16), theanchor implant 150 is smaller for delivering to an implantation site,whereupon the anchor 150 is expanded (FIG. 18) to securely engagetissue. The implant can include a first convex side member 152configured between a pair of concave members 154. The junctions betweenthe members can be looped to provide desired stress relief and aplatform against which the convex member 154 can expand or open.Temporary restraining bands 156 are placed about the looped structure atthe junction between the convex member 152 and each of the concavemembers 154. Further as shown in FIGS. 17 and 19, external surfaces ofthe member 152, 154 can be equipped with tissue penetrating structuresuch as arrow-like barbs 158 or fish hooks 160. One approach toconverting the anchor implant 150 from its contracted state to itsexpanded state is to employ an expandable member such as that of aballoon catheter (not shown). At an implantation site (See FIG. 18), theexpandable member is placed within an interior of the members 152, 154and expanded to facilitate the conversion of the concave members 154 toconvex members. Such action overcomes the restraining bands 156 andfacilitates the advancement of the tissue penetrating structure withtissue.

Another approach to structure for penetrating tissue is shown in FIGS.20 and 21. Here, the penetration structure is embodied in a staple-likestructure 162 including a pair of spaced arms 164 joined at a U 166.Angled barbs 168 are further provided on lateral sides of the arm 164 toprovide a further secure engagement to tissue. In one approach, thestaples 162 are deployed about an anchor implant such that the Ustructure 166 captures the anchor implant and the arms with barbs securethe anchor in place. A threaded base 170 is further provided to connectthe staple 162 to a push rod or wire delivery system (not shown). Inthis way, one or a plurality of staples 162 can be advanced to theimplantation site to help securely set an anchor implant.

Various other approaches to an anchor implant are shown in FIGS. 22-38.FIG. 22 depicts an implant 180 embodying a generally FIG. 8 shapeconnected at its middle by a connection cord 182. A pair of commissuralprojections or feet 184 are further provided and spaced along theimplant to reflect contouring of commissures (points A and B) of a heartvalve. The feet 184 can define loops held in shape by a retaining band186. Another elongate loop 187 is formed at one end of the connectorcord 182 and is configured to extend laterally. The assembly can befurther provided with webbing 188 for tissue ingrowth, the contour ofthe figure 8-shape and the elongate loop 187 providing structure acrosswhich the webbing extends to define a generally circular overall implantbody structure, with the feet 189 extending therefrom.

The approach to the anchor implant 190 shown in FIG. 23 also is embodiedin an assembly having a generally round or circular profile. The implant190 includes a generally circular wire frame 192 having a covering and aplurality of feet, two of which are intended to pass through valvecommissures and a third positioned at a P2 location. A flexible fabricweb 194 is configured across the wire frame 192, the web being centeredabout center points 196 of the valve and including a pair of triangularsections 197 joined by a middle band web section 198.

An anchor implant having a generally T-shaped frame 200 is shown in FIG.24. At a base of the T-frame is a commissural foot 202 configured for P2attachment, whereas the ends of the T-bar of the frame includecommissural feet 204. An expandable web fabric membrane 206 extendsbetween the curvilinear members defining the T-shape frame 200. As shownin FIG. 25, the T-shaped frame 200 can further include a pair of limitedelongation flexible cords 208 each extending from the commissural feet202 at the base of the T-shape frame 200 to one end of the T-bar of theframe.

In yet another approach (FIGS. 26-27), an anchor implant 210 can beembodied in structure designed to prevent turning of an artificial valveattached to the implant 210, and to help in proper seating. Commissuralfeet 212 are configured as before, that is to reside between and belownatural valve commissures. The wire frame of the implant 210 includesfurther larger loops 214 of varying sizes and angled in a manner toengage anterior and posterior walls of the left atrium to therebyprovide lever point support against rotation and structure including theframe from sliding through a valve orifice. Flexible cords 216 arefurther provided to retain the shape of the large loops duringsubsequent implantation of a replacement valve.

Bar-like anchors are also contemplated (See FIGS. 28-38). In oneapproach as shown in FIGS. 28 and 29, the anchor implant 220 can beembodied in a cross-member 222 sized to span a full area of acommissural leaflet. The ends of the cross-member are provided withbroad pads 224, a top portion 226 of which covers the commissuralleaflet and can act to minimize leaking in this area. A bottom portion228 of the broad pads 224 can include a projection through a commissuralof the leaflet, thus providing an anchor function.

As shown in FIGS. 30-32, the anchor implant 230 can include anintra-annular commissural anchoring frame 232 sized and shaped toreceive an artificial valve, or can alternatively be employed to holdanother anchor implant in place during a healing and tissue ingrowthstage. Opposite ends of the implant 230 are curved members 234 which areintended to conform to local anatomy, and extend from above the annulus(intra-atrial), through valve commissures, and to within the LV.Texturing or tissue fabric can be associated or configured upon themember 234. The cross-member 236 connecting the ends of the implant 230also defines a curved member designed to reside in the atrium andfurther includes a band 238 providing both strain relief and supportstructure to the cross-member 236.

Another anchoring frame 240 is shown in FIGS. 33-35. Here, opposite endsof the implant are curved members 242 which are sized and shaped toconform to local anatomy and extend from above the annulus, throughvalve commissures, and to within the LV. The cross-member 244 extendsfrom both ends of the curved end members, and thus is intended to residebelow valve annulus. Cross member 244 resides between the chordal tentof the anterior leaflet chordae and posterior leaflet chordae with thelateral ends extending between the individual chordae out to the LVwall. Because the cross member 244 is a loop like structure it does notentangle in the chordae, stays between the respective anterior andposterior leaflet chords, and helps orient the cross member parallel tothe commissure to commissure line.

In an alternative approach (FIGS. 36-38), a bar-like, anchor frame 250has a generally omega profile sized to span the heart atrium. The endsof the frame 252 are shaped to conform to anatomy, and also extendthrough valve commissures. The curved bar 254 connecting the shaped endsis sized and shaped to reside above the valve annulus.

Moreover, as shown in FIGS. 39-43, it is further contemplated that aring frame of an anchor implant can reside in multiple planes. That is,the frame can embody a saddle shape 260 configured to accommodate thecurvature of a valve annulus such as of the mitral valve (FIG. 39). Theframe can further include an arc section 262 configured to accommodatethe curvature of the inter-trigone anterior leaflet (See FIG. 40).Moreover, the anchor frame can include a serpentine shape 264 (FIG. 41)intended to accommodate dimensional and shape variations of the nativeannulus. The curves of the serpentine pattern can be perpendicular tothe native annulus as shown in FIG. 41, or they can extend horizontallywith respect to the annulus as shown in FIG. 42, or of course a combinedapproach to undulations may be desirable.

With reference to FIG. 43, it is also contemplated that a wire frameanchor implant can include adjustable sub-structure for accommodatingperimeter variations of a valve annulus. Here, a delivery tube 270 canbe configured to advance or retract sections of a wire implant to bestfit it to anatomy. Excess length would be severed and removed. In oneapproach, lengths of posterior frame wire can be so adjusted, leavingunchanged an anterior frame portion 272, and commissural extension 274.Other areas of an anchor implant can also be likewise adjusted asdesired.

Next, various approaches to anchor attachments are presented. As shownin FIG. 44, a direct mechanical load can be placed behind a leaflet 109to provide structural support to an anchor. As previously stated, it isfurther contemplated that the robust anatomy of collagen annulus or atrigone can be relied upon to receive piercing anchors (See FIGS.45A-45B) such as fish-hook 286 or arrowhead-like 288 structure. It hasbeen found that muscle attachment provides excellent ingrowth for stablelong term anchoring. Shear loading is depicted in FIG. 45C and deeper(FIG. 45D), wider (FIG. 45E) and longer areas (FIG. 45F) of anchorpenetration are also contemplated. By taking one or more of theseapproaches, desired and increased holding capability is achieved.

As shown in FIGS. 46-49, one specific approach to a commissuralprojection of an anchor implant can assume a pair of loops 290. Suchloops are intended to be sized so that they can reside under and behinda leaflet 109. Moreover, it is contemplated that the anchor projectionbe made from flexible and elastic material and be able to be inserted ina straightened configuration within a delivery tube 292. A delivery tube292 can be employed for each anchor projection 290, and a connectiondelivery wire 294 is further provided to control positioning. Thus, thedelivery wire 294 can be withdrawn or otherwise disengaged from theanchor projection 290, and to thereby permit release to be reconfiguredinto its looped configuration. This can be done either before or afterejection from the anchor projection 290 from within the delivery tube292. Moreover, individual, releasable control is provided by employing adelivery wire approach. That is, through multiple connections of aplurality of delivery wires to an anchor, desirable control isfacilitated. Catheter/tube access or over-the-wire access approaches arealso contemplated for providing in situ access to each anchoringlocation to deploy both anchor portions and tissue penetratingstructures.

As shown in FIGS. 50 and 51, the anchor projection 30 can also include aleaflet clip configuration 302 attached to its terminal end. The clip302 can also be delivered as described above using a delivery tube andconnection delivery wire 294, so that it is properly positioned, such asbehind a leaflet 109. A flat terminal end 304 of the clip 302 presentsthe valve anatomy with an atraumatic surface, as well as a robustengagement.

In another approach (FIGS. 52-53), an anchor implant 310 can includecommissural projections 312 that extend down and anteriorly to hookunder the fibrous region of the trigone 60, and beyond the annulus. Apenetrating securement element in the form of a helical screw 314 (SeeFIG. 54) can be further deployed through a loop presented by thecommissural projections 312 to further seat and securely attach theanchor implant 310 in place. It is noted that a proximal winding 316 ofthe helical fastener 314 can have a larger profile for positioning on anoutside wall of local anatomy (such as the LV wall). A terminal end 318of the helical element is sized to retain the structures intoengagement.

Other approaches to fasteners are also contemplated (FIGS. 55-61). Asshown in FIGS. 55-56, one device can embody a fastener with a wire brushbody 320 and a nail head terminal end 322 as retaining structure. Otherapproaches involving a variable coil (FIG. 57), a longitudinallydirected coil 324 (FIG. 58) configured parallel to a commissuralprojection, or a curved penetrating ribbon securement markers 326, 328(FIGS. 59-60) can also be useful approaches to providing secureretention of parts against anatomy. Moreover, a commissural projection330 (FIG. 61) can be equipped with a cord extension through which apenetration securement element 332 can be inserted and advanced intobody anatomy to accomplish a necessary attachment function.

It is intended that approaches to sealing may need to provide acontiguous seal between the overall implant (including the implantedreplacement valve) and the native valve tissue/structures to preventregurgitant para-valvular flow. Additionally, contemplated sealingconfigurations are intended to provide for tissue engagement and stableincorporation at the tissue and sealing structure interface. Thesesealing structures may also provide a staged interface to accommodatealternative type valve implant systems, such as the dual parallel valveapproaches where the geometry for valve interface is not the nativeannulus or the anchor implant structure. Sealing structures may includea frame portion, made of metal or other suitable material in a wire orlaser cut configuration. The frame may be covered with a material topromote tissue ingrowth. Additionally or alternatively, the sealingstructure may utilize an expandable member. The expandable member can beballoon inflation, a self-expanding metal frame from a compresseddelivered state, or a self-expanding material such as foam or ahydrogel. The expanding member may be used to directly form the seal orit may be used as a deployment mechanism of another structure. Besidesusing the direct tissue engagement forces designed into the structureand or deployment of the valve assembly, the system can exploit thepressurization of the LV during systole to create the forces needed toseal between the valve assembly and the tissue.

As previously noted, the seal may be incorporated into the anchoritself, incorporated into the valve, or may be a separate structure.Incorporation of the tissue sealing mechanism onto the anchor assemblycan either be achieved acutely or utilize the chronic ingrowth of theanchor into the tissue to generate a seal allowing for a secondary sealbetween the valve and the anchor during its deployment. The secondaryseal can utilize the stability and consistency of the anchor structureto complete the overall seal for the complete valve assembly.

In the situation where the tissue seal is incorporated onto avalve/occluder assembly, the anchor structure is primarily utilized toprovide the load bearing function Where a separate implant structurecreates substrate for sealing, the implant engages the anchor and valveand the seal is created by one of the following; sealing directly to thetissue around the anchor implant creating the primary tissue seal with asecondary seal to the valve, sealing to the anchor and the valve assecondary seals with the anchor as the primary tissue seal, orstructurally bridging the anchor to the valve where the valve createsthe primary tissue seal.

Furthermore, to develop an acute seal between the native tissue and thespecific element of the overall valve assembly, direct force between thevalve assembly and the tissue can be used. Alternatively, thepressurization of the LV during ventricular systole can be used to“inflate” or pressurize an element on the valve assembly such that itengages the native tissue to create a seal.

In one approach, for the interface between the anchor and the tissue,simple surface contact between the surfaces can facilitate sealingthrough tissue ingrowth. Additionally the anchor skeleton can provide anexpansion force to create a compressive interface. In certainembodiments of the anchor, dilatory or pinching like forces can becreated at certain regions of the anchor.

Mechanisms to create engagement between the anchor and valve can includeballoon expansion of valve frame into anchor structure, orself-expansion of valve frame into anchor structures. Additionally, ahook-like engagement where the valve frame clasps or hooks onto anchoror anchor and tissue can be used as can a frictional fit between thestructures, the same being created via balloon or self-expansion of thevalve frame into the anchor. Interlock mechanisms where the valve frameengages the anchor ring can be employed as can conformable balloon ormaterial interface.

For a tissue/valve interface, dilation of the valve or valve frameelements can be utilized. Also contemplated is a simple surface contactto facilitate ingrowth of tissue onto valve structures, compression andexpansion elements on the valve frame for directly engaging the tissue,inflation of a valve structure via the LV pressure, and then deploymentof hooks or structural frame elements enhance or create tissueengagement. It is further noted that the various sealing structuresdisclosed can be adapted to either be part of the anchor structure, partof the valve structure, or be an independently delivered structure.Moreover, all disclosed features can be utilized individually or in anycombination. Surface composition elements, specifically material choiceand texture to promote tissue reaction and device incorporation withmaximal sealing capability, may have a significant impact on sealingcapabilities. Specific sealing modifications can include surface texture(pores to promote ingrowth and mechanical hold), material choice (Dacronvelour, double velour, ePTFE), abrasive surfaces, and/or a chemicalirritant to promote inflammatory response. Further, tissue surfacemodification can involve abrasive chemical irritant to promoteinflammatory response, and the use of heat.

Accordingly, as shown in FIGS. 62 and 63, an anchor implant 450 caninclude an internal ring 452 surrounded by a covering 454 adapted fortissue ingrowth. As stated, tissue ingrowth cooperates with theengagement of the anchor implant 410 to create a seal against hearttissue. As before, the anchor implant is sized and shaped to fit theheart valve annulus.

Sealing can also be accomplished by employing petals 460 arranged abouta circumference of an expandable frame 462 (See FIGS. 64-67). As shownin FIG. 67, the valve assembly can assume a compressed configuration fordelivery and then expanded upon implantation. Selected such petals 460can be arranged to engage a valve annulus or alternatively can beconfigured to engage the leaflets themselves. A foldable fabric 464 canfurther be provided about the petals to facilitate sealing and acontinuous engagement about a perimeter of a valve.

As shown in FIGS. 68-72, an expandable ventricular ring 470 can also beused to accomplish desired sealing. Here, a pair of longitudinallyspaced circular frames 472, 474 support a fabric covering 476. The lowerframe 474 expands outwardly to engage tissue and provide the sealingfunction against tissue. It is contemplated that the first frame 472resides above the valve annulus and the second frame 474 engages anatomybelow the annulus. In this situation, the seal between the nativetissue/leaflet with frame 474 is facilitated by the LV pressurization ofthe internal surface of the frame 474 and fabric 476 as well as theunderside of the leaflets pushing the tissue and frame 474 against eachother.

With reference to FIGS. 73-75, a fluid filled balloon 480 can also beincorporated into sealing structure. The balloon 480 can define aring-shaped structure which when expanded engages and seals againstvarying heart anatomy. The assembly can further include commissuralengagement anchors 482, the same being defined by a wire frame. Adownwardly projecting frame 484 can also be included to aid in absorbingforces tending rotate the assembly when implanted at the native valve.

With reference to FIGS. 76-78, a sealing assembly 490 can also embody ananchor ring 492 partially enclosed by a ring balloon 494. The anchorring 492 engages tissue at the valve annulus and the circular balloon494 forms a “C” about the anchor ring 492 when viewed in cross-section,thereby presenting two additional contact points with anatomy about theperimeter of a valve. Such structure provides a seal between theassembly and heart anatomy as well as between the anchor ring 492 andring balloon 494 through an interlocking engagement. A circular band 496placed at the junction between the balloon 494 and anchor ring 492 canlimit expansion of the balloon 494 and facilitate its surrounding theanchor ring 492.

As shown in FIGS. 79-82, a sealing assembly 500 can alternatively embodya circular frame 502 including a plurality of vertically arranged,expandable wire struts 504 spaced about a periphery of the frame 502.Configured between a central frame structure 506 and the expandablestruts 502 is an expandable circular balloon 508. Upon expansion of theballoon 508, the expandable struts 504 expand outwardly and thus canengage and bend around an anchor implant 509 placed at theinterventional site. Such bending forces created by the expanded balloonoperate to seal the assembly 500 against the anchor 509 and valveanatomy.

FIGS. 83 and 84 depict an additional two approaches to sealingstructures. In each, a frame is contoured with a fabric covering 510.The frame can be formed from a wire mesh 512 (FIG. 83) or can be definedby an expandable metal frame 514 (FIG. 84). Again, such structure isintended to sealingly engage within heart anatomy and when desired,about an anchor implant.

Moreover, as shown in FIGS. 85-87, sealing can be created by a flexiblepolyester skirt 520 which expands outwardly in response to pressureswithin the heart. The expandable skirt 520 can be configured about anextremity of a frame of a heart valve that is additionally supported bycommissural anchors 522 extending to within the LV. Over time, tissueover growth covers the skirt 520 providing further attachment andsealing.

Various approaches to expandable strut structure are also contemplatedfor use as sealing structures (See FIGS. 88-100). In a first approach(FIGS. 88-90), an expandable frame 530 can include a plurality of rowsof cells, a middle row of cells include members which expand outwardlyto engage an anchor implant 532 about a periphery of an annulus. Inanother approach (FIGS. 91-93), a sealing frame 540 is embodied in abraided and folded wire mesh structure. An internal portion of the fold542 attaches to a valve structure 543, whereas a portion of an outersection 544 of the folded wire mesh engages and forms about an anchorimplant frame 546. In yet another approach, the sealing frame can bedefined by folded metal wire forming structure 550 including indentedgeometry 552 for engaging an anchor frame 554 and an inner layer whichcan support valve leaflets 556 (See FIGS. 94-95). Other expandable framedesigns are shown in FIGS. 96-99. One such design 560 (FIGS. 96-97)embodies a frame 562 which expands into a tubular shape with a mid-levelindentation 564 formed by smaller slits and sized to engage an anchorimplant, and a second design 570 (FIGS. 98-99) expands into a tube witha series of upper and lower projections 572 spaced longitudinallyproviding a space to receive an anchor.

In still yet another approach (FIGS. 100-102) a compressible material580 can be employed to create or facilitate sealing. The compressiblematerial can define a ring structure about a valve 582 and placed intoengagement with an anchor 584. The compressible material can be madefrom a foam or hydrogel and thus act as an interlocking element.

Additionally, the sealing device can be embodied in a ring 590 includingcommissural projections 592 including barbs 594 (FIG. 103). Placement ofa valve assembly with the ring 590 helps maintain the barbs 594 inplace. Moreover, a sealing ring 600 can conform about and beyond theannulus and between papillary muscles and cooperate with projections 602extending from an anchor to accomplish secure implantation (See FIGS.104-106). Furthermore, as shown in FIGS. 107-108, a sealing device 610can cooperate with a plurality of projections 612 extending from avalve, as well as a hooked attachment member 614 that is inserted intotissue as an anchoring structure.

Various other tubular sealing assemblies are shown in FIGS. 109-115.Turning in particular to FIGS. 109-111, a tubular sealing assembly 620can include an expandable tubular frame 622 and a membrane perimeter 624extending about a midsection thereof. Upon expansion of the tubularframe 622, the midsection of the frame 622 opens to the profile definedby the membrane 624 to thereby present a sealing interface structure.Alternatively, an expandable wire frame 630 can be unconstrained by amembrane and extend to match body anatomy (FIG. 112) or it can be asealing device 640 including a compressible material band 642 about itsmidsection as well as an additional sealing ring 644 (See FIG. 113)attached to its leading edge.

In yet another approach (See FIGS. 114-115), the sealing device 650 caninclude a pair of wire extensions 652 sized and shaped to extend withinthe LV between papillary muscles. A wire 654 with a sheath 656 at is tipcan be used during delivery of the sealing device 650 to theimplantation site. Once placed as desired, the structure can bedisengaged from the wire extensions 652, permitting them to engagesupporting anatomy within the LV. In order to provide a surface tocapture anterior and posterior leaflets, the wire extensions can assumea coiled configuration when deployed.

The delivery system and method used to deliver the anchor system candepend on both the structure and type of materials used for the anchor,as well as the desired route of access for implantation, and the type ofdeployment of the anchor. An anchor delivery system can generallyinclude a guide catheter and an anchor delivery catheter, either asseparate components, or integrated together. The guide catheter mayinclude specific curves to facilitate navigation into the atrium orventricle and may also include a steerable torquable shaft to aid withanchor positioning or orientation. The guide catheter may furtherinclude a deflectable tip region. The anchor delivery catheter can houseor hold the collapsed anchor during delivery and deployment and mayinclude delivery tubes or wires that are releasably connected to theanchor. Other elements such as shaft dividers may be utilized to helpwith managing multiple connection shafts as well as orientation of theanchor during deployment. Additional components inside the connectionshaft or wires, or deliverable through or over, may include tissuepenetrating elements to aid with overall securement and anchoring. Aproximal hub can be configured to function to selectively manipulate,seal, and deploy certain elements. It is contemplated that structurescan be incorporated onto the anchor to allow for a percutaneous deliveryand include the use of super elastic Nitinol for the primary skeleton ofthe anchor or the use of a malleable SST or a similar material thatcould be folded down inside the delivery catheter but then balloonexpanded against the tissue interface and would conform mitral tissueinterface. The use of heat set small radii in certain locations of theanchor structure can allow for folding to fit inside delivery catheterwhere the strain limit of the material is not exceeded. Also, the use ofribbon at certain locations within the anchor skeletal structure canallow for tight bends in the thinner dimension for bending insidecatheter, but still achieve the structural rigidity required if thebroader section of ribbon is properly oriented when deployed. Smallerand larger diameter wire can also be used to vary the configuration toallow for bending/collapse in the catheter while still having thenecessary structural strength and interface when deployed.

It is further contemplated that the anchor structures allow for arterial(aorta-retrograde), venous (via transatrial septum-antegrade),trans-apical (LV), or trans-atrial via a right thoracotomy access intothe left atrium. Because of the relatively small size of the anchor, theability to compress or fold the anchor into a small deliveryconfiguration (especially with Nitinol or malleable stainless), and theseparation of the anchor from the valve, the arterial route is feasibleand may be especially useful in the situation where the anchor isdeployed at the time of a diagnostic angiogram that is in advance of theactual valve therapy (separate procedures), as the arterial groin accesshas already been created. Routes of access can include arterial, venousand/or thorax/apical.

To deploy the anchor into the heart, both catheter sheath retraction andanchor push out of sheath are contemplated approaches. Also, to have theanchor achieve the desired configuration inside the heart, either aself-expanding anchor, or use of balloon expansion to expand the anchor,or components of both are contemplated.

For anchors that are supra-annular with commissural feet, deliverysystem connections to the tips of the commissural feet or projectionscan facilitate positioning and proper orientation and seating into themitral orifice. In this regard, the anchor and connections would exitthe delivery catheter while the catheter tip was residing in the leftatrium. The delivery sheath could then be pulled down beneath the levelof the mitral annulus allowing the shaft connections to the feet toorient and align with the commissural clefts of the anterior annulusbetween the anterior and posterior native leaflets. As the shaftconnections are pulled, the commissural feet would move toward the edgeand bring the feet into position next to the LV wall within the naturalleaflet cleft. Once in this position, additional features of theimplants could be deployed or delivered via the shaft connections usedto aid in attaching the feet to the wall/leaflet tissue, e.g. staple,barbed hooks or nails. Similar feet could be utilized for orientationalong the clefts seen naturally on the P1 and P3 regions of theposterior leaflet.

According to one aspect, an exemplary embodiment of the delivery systemutilizes an outer delivery or guide catheter that has a pre-formed curvethat positions the anchor delivery catheter into the proper orientationtoward the mitral valve from the LV. For retrograde access to the LVfrom the aorta, curves ranging from 90 to 200 degrees may be used. Apre-formed shaft separator or a shaft separator with prespecifiedbending moments within the guide catheter can also aid in orienting andpositioning the anchor and associated connection shafts.

According to another aspect, an exemplary embodiment of a deliverysystem may include connection shafts to connect to and control movementof the commissural feet of the anchor being deployed. The connectionshafts can be tubular or wire structures or combinations that canrelease ably disengage from the anchor after positioning. Theseconnection shafts can allow for independent manipulation of the anchorat each individual point of attachment.

The anchor securement elements can be deployed utilizing the two basicstructures of the shaft connections to the anchor frame and/orprojections, namely the tubular shaft and the wire connections providingthe temporary securement. The tubular shaft can be retracted to deployan expanding frame element housed inside the shaft during framedelivery. Also, the tubular shaft can be used as a conduit to deliver aseparate structure to the attachment location and/or to expose or deploya securement element and then used to either actuate or drive theelement by re-advancing the tube. Further, a wire element can be used asa conduit or rail to deliver a separate structure to the attachmentlocation. The wire element can also be used to deploy or push out anelement loaded/housed inside the tube/wire structure and/or the wirestructure can be used by rotating an element connected at its tip todeliver the securement element.

With reference to FIGS. 116-127, one delivery system and method ispresented. In a first step (FIG. 116), a j-tip guidewire 700 is advancedwithin the heart through the aortic valve AV. Conventional methodsincluding those outlined above are employed to gain access to the aorta.Next, an intraventricular guide catheter 702 is advanced over or alongthe guidewire 700 (FIG. 117). The distal tip 704 of the guide catheter702 is oriented toward the mitral valve MV, with a curve plane of thecatheter being parallel to the A2/P2 orientation. The guidewire 700 (ora second guidewire) is then advanced through the orifice of the mitralvalve MV, thereby providing a platform for placing structure across themitral valve MV (See FIGS. 118-119).

With the guidewire 700 across to the mitral valve MV, a balloon orexpandable cage 710 is configured within the orifice of the mitral valveMV (See FIGS. 120-121). It is to be recognized that the guidewire 700can be equipped with the balloon or expandable cage 710, or a separatedevice can be advanced over the guidewire 700, and the balloon or cage710 placed within the orifice of the mitral valve MV. In one embodiment,structure is provided to withdraw a distal portion of the balloon orcage 710 relative to proximal structure to thereby expand the balloon orcage 710, or a sleeve structure can be advanced relative to a distalportion of the balloon or cage to accomplish the expansion. It is alsocontemplated that the balloon or cage 710 be expanded in the left atriumLA and then withdrawn within the orifice of the mitral valve 710 toensure there is no entanglement with cords 712 supporting the mitralvalve with any portion or components of the delivery system. The balloonor cage 710 is then contracted and removed from within the orifice ofthe mitral valve MV, or otherwise covered with other structure of thedelivery system.

If the wire cage meets a restriction, the cage can be collapsed and itand wire can be withdrawn back into guide and non-entangled wire accessattempted again. Alternatively, the expanded wire cage could be advancedfirst until it passes mitral orifice without restriction. The size ofthe cage is large enough to fit through orifice but not between chordaeattached to the same papillary muscle, and traverses between chordaltent and anterior and posterior leaflets. The wire is then advanced intoatria to provide anchor system delivery that does not entangle withsubvalvular mitral apparatus. Alternatively, a balloon tipped cathetercan be utilized instead of a cage. Once the wire is successfully placed,the wire cage or balloon system is removed from body leaving wire accessfor the next steps of anchor delivery.

As shown in FIGS. 122 and 123, an anchor delivery catheter 720 is nextadvanced over the guidewire 700 and within the guide catheter 702. Alength of the anchor delivery catheter 720 is placed across the orificeof the mitral valve MV. Subsequently (See FIGS. 124 and 125), the anchorimplant 730 is advanced out of a terminal end of the anchor deliverycatheter 720 and into the left atrium LA. Proper orientation of theanchor implant 730 is provided by a plurality of connection wires 740.Such wires 740 are each connected to a single commissural projection 744of the anchor implant 740, so that one commissural projection 744 isaligned with each trigone T, and one commissural 744 is aligned with theposterior leaflet segment P2. Connection between wires 740 andcommissural projection 744 is maintained until proper positioning isensured, and so that reorientation and retrieval is possible.

Once the positioning of the anchor implant 740 is verified, the anchordelivery catheter 720 and connection wires 742 are withdrawn to placethe anchor implant 740 within the annulus of the mitral valve MV. Whenplaced as desired, a commissural projection 744 is placed at each thetrigone T, and one at P2 (See FIGS. 126-127). As can be best appreciatedfrom FIG. 125, a shaft 750 having three or more longitudinal boresformed therein can be employed to push the anchor implant 720 out froman interior of the anchor delivery catheter 720. The longitudinal boresprovide conduits for the connection wires 742 used to orient the anchorimplant 730. A central longitudinal bore (not shown) can be furtherprovided to receive the guidewire 700; however, in the event the shaft750 does not include a central bore, the guidewire 700 is removed fromthe interventional site prior to the advancement of the anchor deliverycatheter 720 within the guide catheter 702.

In an alternative approach to the anchor delivery catheter (See FIGS.128-132 shown without an anchor), a longitudinal shaft separator 760 canbe employed in place of the above-described shaft. Thus, rather thanhave a plurality of longitudinal bores sized to receive the connectionwires 742, the shaft separator 760 includes a plurality of splines 762extending from a central core to define spaces for the connection wires747. A central bore 764 is further provided to slidingly receive theguidewire 700. As shown in FIGS. 128 and 129, the splines 762 can beplaced at varying locations to facilitate proper orientation ofstructure within the anchor delivery catheter 720 such as byauto-orienting connection wires to a plane of the oriented guidecatheter. For example, one spline 766 can be sized and positioned toorient along an inner radius 768 of a curve of the delivery system (SeeFIG. 132). The curve of the shaft separator 760 aligns and maintainsrotational orientation of the separator splines relative to the curve ofthe anchor delivery catheter 720 or the guide catheter 768.

Moreover, with reference to FIGS. 133-135, various alternatives arepresented regarding releasable connections between commissuralprojections and structure of the anchor delivery system 720. In oneapproach (See FIGS. 133-134), a commissural projection 770 of an anchorimplant can include a deployable staple 772. The deployable staple 772is configured within the anchor delivery catheter or a separate sheath774 of the anchor delivery system. A positioning rod 776 with a threadedterminal end is joined to internal threads formed within the deployablestaple 772 to define a threaded connection 778 between the parts.Further, a retainer cord 780 is placed through the sheath 774, the sameincluding a loop 782 configured about the positioning rod 776 and aterminal end 784 engaging the commissural projection 770. In this way,distinct point controls are provided to separately position and deploythe staple 772 and the commissural projection 770. That is, the retainercord 780 can be withdrawn from engagement with the commissuralprojection 700 to facilitate its implantation separately from deployingthe staple by rotating the position rod 770 from engagement with thestaple 771.

In an alternative approach (See FIG. 135), a threaded connection 790 canbe provided between a threaded receiver 792 formed on the anchor itself,and a threaded connection wire 794. Here, a delivery connector tube 796includes a first large bore 797 sized to receive the commissuralprojection 798, and a second smaller bore sized to slidingly receive theconnector wire 794. Again, distinct point control is provided in thatthe commissural projection 798 can be released independently ofdisengagement of the threaded connection 790.

Percutaneous, or minimally invasive trans-apical, valve delivery systemstypically can be over the wire systems with the valve assemblycompressed or crimped into the delivery state. To expose the valve, theouter catheter structure or sheath can either be withdrawn or theimplant pushed or expelled from the outer catheter. The tip of the valvedelivery system can also include a tapered and flexible tip section tofacilitate navigation and tracking of the system within the vasculatureor heart. Once exposed the valve is either self-expanding or balloonexpanding. Some releasable connection shafts or wires to the valve framemay also be incorporated to facilitate positioning and orientation.

Various loading methods and structures are contemplated. Tools such ascrimping devices can be utilized for compressing the valve down onto thedelivery catheter shaft and into a deliverable configuration and size.Moreover, a primary route of access for a replacement mitral valve canbe via a venous trans-septal antegrade approach. It is also anticipateda transapical approach can be utilized. A trans-atrial approach via aright thoracotomy to gain access to the left atrium can also be used andmay be useful when utilizing a mechanical valve for implantation. Thus,routes of access can include arterial, venous and/or thorax/apical.

Various deployment methods are also contemplated. The deployment of thevalve can utilize any of the current techniques being employed forpercutaneous pulmonic or aortic implantation. This includes retractionof a sheath or advancement of the valve inside the sheath to have thevalve exit the delivery catheter. Once exited, either partially orcompletely, the final valve deployment could include self-expansion orballoon expansion. With either of these final deployment techniques, anondeployed interlock structure/mechanism on the perimeter of theartificial valve could provide a temporary space for flow communicationof the atria with the ventricle during diastole during artificial valveexpansion. Upon completion of artificial valve expansion, it would nowbe functional and the interlock mechanism could now be deployed tocomplete the anchoring and sealing of the artificial valve. Thisparticular embodiment can eliminate the conventional need for rapidpacing during valve deployment; there is flow allowed during diastolewhile valve is deployed. Therefore, each of retraction, push,self-expanding, and balloon approaches are contemplated.

With respect to orientation/positioning methods, utilizing a separatelyimplanted anchor substrate is the ability to utilize a fluoroscopicalignment technique to mesh the anchor with the valve. In this scenario,the x-ray fluoroscopic camera could be adjusted so a radiopaque(complete or interrupted around perimeter) anchor structure would bevisualized in a relatively straight line (camera orientation—lineconnecting emitter with intensifier—is perpendicular to anchor circularaxis, or parallel to plane of anchor ring). The valve frame structurecould similarly have a radiopaque perimeter at the point at or near theinterlock region with the anchor. When the anchor was viewed in themanner described, the valve axial orientation could be adjusted so theradiopaque perimeter was also a line (without moving camera position)meaning the two cylindrical axes of the anchor and valve were nowparallel. Subsequently, the valve line could be appropriately positionedabove, below, or at the interlock region. This linear alignment of thetwo radiopaque structures would be even more visually pronounced as thevalve frame was being expanded/deployed, whether by balloon orself-expanding. This could additionally allow for fine tuning oradjustment prior to final engagement of the valve with the anchorstructure.

With references to FIGS. 136-142, various steps to placement of anartificial mitral valve are presented. FIG. 136 shows the anchordelivery system 800 placed within the heart subsequent to implantationof an anchor implant 802. In one approach, the anchor implant 802 isleft to heal in place prior to deployment of the artificial valve.Alternatively, as stated above, valve implantation can be conductedalong with or just subsequent to the placement of the anchor implant802. Using a transarterial approach, as shown in FIGS. 137-138, anartificial valve delivery system 810 is advanced in a transvenous,trans-septal approach to position an artificial valve 820 intoengagement with the anchor implant 802. In order to properly orient theanchor implant 802 and valve 810 relative to each other, each of theanchor implant and valve can include radiopaque markers. Anchorradiopaque markers 822 and valve radiopaque markers 824 can thus bealigned both longitudinally or axially (See FIGS. 139-140) as well asrotationally (See FIGS. 141-142). In this context, a fluoroscopic camera(not shown) can be employed to guide the relatively positionalrelationship between anchor 822 and valve 824 markers. It is to befurther noted that radiopaque markers residing on a commissuralprojection of an anchor implant can further be used to ensure that theyare seated as desired between commissures, and markers located on a ringportion of an implant can be used to locate such structure at a valveannulus.

Turning now to FIGS. 143-146 and FIGS. 147-150, an alternativetrans-atrial approach and a trans-apical approach to artificial valvedelivery are depicted. Here, a valve delivery system includes anintroducer tool 828 which is insertable through a portal assembly 830.The portal assembly 830 has a generally flat, oval cross-sectionalprofile intended to present a less invasive structure to heart tissue.The introducer tool 828 further includes an articulating terminal endportion 832 adapted to releasably hold an artificial valve 834. Theterminal end portion 832 is configured to retain a tilted valve 834 (SeeFIGS. 143-144 and 147-148) for insertion into an interior of the heartthrough the portal assembly 830, and is articulatable so that theartificial heart valve 834 can be turned and placed into engagement withan anchor implant 840 previously delivered at the native valve (SeeFIGS. 145-146 and 149-150). Notably, the portal assembly 830 furtherincludes purse string sutures 842 configured about an exterior surfaceof a portion of the assembly located at the point of heart insertion.Upon removing the portal assembly 830 from the interventional site, thepurse strings are intended to remain in place on the heart and are thusavailable to close the access point employed for the valve insertion. Inthis way, the implantation procedure is completed expeditiously with arepaired access point.

Further modifications and alternative embodiments will be apparent tothose of ordinary skill in the art in view of the disclosure herein. Forexample, the systems and the methods may include additional componentsor steps that were omitted from the diagrams and description for clarityof operation. Moreover, those of ordinary skill in the art willappreciate that aspects and/or features disclosed with respect to oneembodiment in some case may be incorporated in other embodiments even ifnot specifically described with respect to such other embodiments. It isto be understood that the various embodiments shown and described hereinare to be taken as exemplary. Elements and materials, and arrangementsof those elements and materials, may be substituted for thoseillustrated and described herein, parts and processes may be reversed,and certain features of the present teachings may be utilizedindependently, all as would be apparent to one skilled in the art afterhaving the benefit of the description herein. Changes may be made in theelements described herein without departing from the spirit and scope ofthe present teachings and following claims. Accordingly, thisdescription is to be construed as illustrative only and is for thepurpose of enabling those skilled in the art the general manner ofcarrying out the present teachings. It is to be understood that theparticular examples and embodiments set forth herein are nonlimiting,and modifications to structure, dimensions, materials, and methodologiesmay be made without departing from the scope of the present teachings.Other embodiments in accordance with the present disclosure will beapparent to those skilled in the art from consideration of thespecification and practice of the invention disclosed herein. It isintended that the specification and examples be considered as exemplaryonly, with a true scope and spirit being indicated by the followingclaims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

We claim:
 1. A mitral valve replacement system configured to beimplanted in multiple stages to treat a heart having a mitral valveincluding commissural clefts, at least a posterior leaflet and ananterior leaflet to provide a mitral valve leaflet function of occludingflow during systole and opening flow during diastole, and an annulus,comprising: an anchoring structure including a supra-annular retentionstructure and anchoring elements that are configured to engagesub-annular structure of the mitral valve to position the anchoringstructure relative to the mitral valve without significantlyinterrupting the mitral valve leaflet function of occluding flow duringsystole and opening flow during diastole; and an artificial valveconfigured to be received by the supra-annular retention anchoringstructure after the anchoring structure is placed separately within theheart; wherein the artificial valve is sized and shaped such that anupper portion of the artificial valve mates with the supra-annularretention structure at a position spaced supra-annularly of the mitralvalve annulus while a lower portion of the artificial valve extends to aposition sub-annularly of the mitral valve annulus, wherein theanchoring elements of the anchoring structure comprise a plurality ofwire loop projections configured to pass through a commissural cleft andthe engage sub-annular structure.
 2. The mitral valve replacement systemof claim 1, wherein the anchoring structure is sized and shaped to beimplanted at a mitral valve annulus without reshaping the annulus. 3.The mitral valve replacement system of claim 1, the anchoring structurefurther comprising a projection configured to engage the mitral valveannulus along a posterior leaflet.
 4. The mitral valve replacementsystem of claim 1, the anchoring structure further comprising annulusengaging structures having shapes configured to mimic contours of theannulus of the mitral valve.
 5. The mitral valve replacement system ofclaim 1, wherein the anchoring structure is movable between a compressedconfiguration and an expanded configuration.
 6. The mitral valvereplacement system of claim 1, wherein the anchoring structure isconfigured for tissue ingrowth.
 7. The mitral valve replacement systemof claim 1, the anchoring structure further comprising projectionsconfigured to engage a mitral valve trigone.
 8. A mitral valvereplacement system configured to be implanted in multiple stages totreat a heart having a mitral valve including commissural clefts, atleast a posterior leaflet and an anterior leaflet to provide a mitralvalve leaflet function of occluding flow during systole and opening flowduring diastole, and an annulus, comprising: an anchoring structureincluding a supra-annular ring-like structure and anchoring elementsthat are configured to engage sub-annular structure of the mitral valveto position the anchoring structure relative to the mitral valve withoutsignificantly interrupting the mitral valve leaflet function ofoccluding flow during systole and opening flow during diastole; and anartificial valve configured to be received by with the supra-annularring-like anchoring structure after the anchoring structure is placedseparately within the heart; wherein the artificial valve is sized andshaped such that an upper portion of the artificial valve mates with thesupra-annular ring-like structure and remains spaced supra-annularly ofthe mitral valve annulus while a lower portion of the artificial valveextends to a position sub-annularly of the mitral valve annulus, whereinthe anchoring elements of the anchoring structure comprise a pluralityof wire loop projections configured to pass through a commissural cleftand the engage sub-annular structure.
 9. The mitral valve replacementsystem of claim 8, wherein the anchoring structure is sized and shapedto be implanted at a mitral valve annulus without reshaping the annulus.10. The mitral valve replacement system of claim 8, the anchoringstructure further comprising a projection configured to engage themitral valve annulus along a posterior leaflet.
 11. The mitral valvereplacement system of claim 8, wherein the anchoring structure has acurved portion.
 12. The mitral valve replacement system of claim 8,wherein the anchoring structure is movable between a compressedconfiguration and an expanded configuration.
 13. A mitral valvereplacement system configured to be implanted in multiple stages totreat a heart having a mitral valve including commissural clefts, atleast a posterior leaflet and an anterior leaflet to provide a mitralvalve leaflet function of occluding flow during systole and opening flowduring diastole, and an annulus, comprising: an anchoring structureincluding a supra-annular retention structure and anchoring elementsthat extend below the supra-annular retention structure and areconfigured to engage sub-annular structure of the mitral valve toposition the anchoring structure relative to the mitral valve withoutsignificantly interrupting the mitral valve leaflet function ofoccluding flow during systole and opening flow during diastole; and anartificial valve configured to sealingly engage with natural tissue andto be received by the supra-annular retention anchoring structure afterthe anchoring structure is placed separately within the heart; whereinthe artificial valve is sized and shaped such that an upper portion ofthe artificial valve mates with the supra-annular retention structure ata position spaced supra-annularly of the mitral valve annulus while alower portion of the artificial valve extends to a positionsub-annularly of the mitral valve annulus, wherein the anchoringelements of the anchoring structure comprise a plurality of wire loopprojections configured to pass through a commissural cleft and theengage sub-annular structure.
 14. The mitral valve replacement system ofclaim 13, wherein the anchoring structure is sized and shaped to beimplanted at a mitral valve annulus without reshaping the annulus. 15.The mitral valve replacement system of claim 13, the anchoring structurefurther comprising a projection configured to engage the mitral valveannulus along a posterior leaflet.
 16. The mitral valve replacementsystem of claim 13, wherein the seal is created by sealing against anative leaflet.
 17. The mitral valve replacement system of claim 16,wherein the seal is created without reshaping the annulus.